Sheath device for inserting a catheter

ABSTRACT

In a sheath device for inserting a catheter into a patient&#39;s body, comprising a first sheath having a proximal end and a distal end, wherein when used as intended the distal end of the first sheath is provided for arrangement in the patient&#39;s body and the proximal end of the first sheath is provided for arrangement outside the patient&#39;s body, and wherein the first sheath comprises a tubular section and a sheath housing, which is disposed at the proximal end of the section and comprises a receiving channel for a catheter, according to the invention the tubular section is detachably held in a clamping element of the sheath housing in a non-positive manner so as to be able to easily shorten the tubular section.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/474,592, filed Mar. 30, 2017 (now allowed), which is a continuationof U.S. application Ser. No. 13/261,902, filed May 21, 2014, which is anational stage entry of PCT/EP2012/076587, filed Dec. 21, 2012, whichclaims the benefit of U.S. Provisional Patent Application No.61/579,198, filed Dec. 22, 2011, and European Patent Application No.11075272.2, filed Dec. 22, 2011. The disclosures of each of theforegoing applications are incorporated herein by reference in theirentirety.

TECHNICAL FIELD

The invention resides in the mechanical field and can advantageously beused in medical engineering. It relates to a sheath device for insertinga catheter into a patient's body, wherein the sheath leads into thepatient's body and a proximal end of the sheath protrudes therefrom. Thesheath provides a lumen, through which a catheter can be inserted intothe patient's body.

BACKGROUND OF THE INVENTION

Such sheath devices are known in principle. They are used to insertvarious catheters, for example in the minimally invasive medical field.Such a sheath can, for example, be provided for inserting a blood pumpfor cardiac support, such a unit comprising a distal pump unit, a hollowcatheter and a drive shaft which is guided through the hollow catheter.In miniaturized form, such pumps are often times designed so that theycan be radially compressed and inserted, in the compressed state,together with the catheter through a blood vessel of the body. The pumpcan then be expanded at the site of use, for example in a blood vesselor in a ventricle. In the expanded state, with delivery elementsactivated, such a pump can then attain the required pumping capacity.

In addition to such compressible heart pumps, other functional elementsare also conceivable, which are introduced into a cavity of a body bymeans of a sheath according to the invention, such as stents or millingheads for removing plaque from vessels.

Compared to a direct insertion, inserting such functional elements andcatheters by means of a sheath is considerably easier and alsoassociated with fewer medical risks.

The sheath itself can be inserted, for example into a vascular system,using the known Seldinger Technique. For this purpose, first an openingis introduced in a body vessel by means of a puncturing needle,whereupon a guide wire is pushed in. A dilator is then optionallyintroduced via the guide wire, and thereupon the sheath itself is pushedin. The guide wire can then be removed, unless it is required forfurther guide tasks, and other elements can be introduced via thesheath.

A corresponding method is known from WO 02/43791, for example. Accordingto this document, a heart pump is advanced along a guide wire into theleft ventricle of a patient and a pump unit is advanced out of thesheath through the vascular system to the ventricle.

A corresponding fluid pump, which is provided for high rotational speedsso as to achieve a corresponding pumping capacity, in the form of ablood pump is likewise known from WO 02/43791 A1, but also from EP2047872. EP 2047872A1 describes a pump which comprises a distal pumpunit, to which a proximal shaft hollow catheter adjoins. A drive shaftextending in the shaft catheter is connected to a drive unit for drivingthe rotor of the pump.

Using a convenient sheath for inserting a catheter, notably comprising adrive shaft, has the advantage that the catheter, and more particularlya drive shaft, experiences less mechanical stress during insertion. Thisis advantageous in particular with high mechanical stresses to which adrive shaft is exposed when a blood pump is operated.

For a convenient use of a corresponding sheath for inserting a catheter,notably comprising a distal pump unit, it is desirable to be able toadvance the sheath, together with the hollow catheter, as close aspossible to the vicinity of the site of use and then remove the shaftcatheter or the pump from the sheath, so as to then be able to retractthe sheath at least a certain distance. The unit to be introduced isthus moved the shortest possible distance in the vascular system orcorresponding cavities of the patient's body outside a sheath, so thatthe strain on the vascular walls due to insertion of the foreign objectas well as the mechanical stress of the unit to be inserted aresubstantially reduced.

On the other hand, such a procedure requires a corresponding excesslength of the sheath, which after being advanced and subsequentlyretracted typically protrudes a certain distance from the patient'sbody.

BRIEF SUMMARY OF THE INVENTION

It is the object of the present invention to advantageously design acorresponding sheath device so that it is particularly easy to handle.

According to the invention, a sheath device for inserting a catheterinto a patient's body comprises a first sheath having a proximal end anda distal end, wherein the distal end of the first sheath is disposedinside the patient's body when the sheath is used as intended, while theproximal end protrudes from the patient's body. The first sheathadditionally has a tubular section and a sheath housing, which isdisposed at the proximal end of the section and comprises a receivingchannel for a strand-shaped body, and more particularly for a catheter.

Because the tubular section is detachably held in a clamping element ofthe sheath housing in a non-positive manner, the sheath device can firstbe pushed into the patient's body by a certain distance so as to insertthe catheter into the patient's body, the catheter can then be extractedand the sheath device can be pulled a certain distance out of thepatient's body. The tubular section can then be released from theclamping particularly easily, and it can be shortened and re-clamped.

This makes it particularly easy to cut the sheath device to the suitablesize after use, so that it does not protrude from the patient's body anyfurther than necessary.

According to an advantageous embodiment of the invention, the tubularsection can be displaced into the sheath housing when the clampingelement is released. The tubular section can thus be accommodated in thesheath housing, removed within the sheath housing or removed through aproximal opening of the sheath housing.

It seems to be particularly useful for the tubular section to lead intothe sheath housing in direct extension of the receiving channel for thecatheter. This design makes the insertion of a catheter into the tubularsection particularly simple, in that the catheter is first inserted intothe sheath housing, guided in the receiving channel thereof and thusdirected without effort to the mouth of the tubular section. It can thusbe assured that the insertion of the catheter into the proximal end ofthe sheath device is simplified and can be reliably carried out.

This design also allows the proximal end of the tubular section of thesheath to be easily pushed into the receiving channel inside the sheathhousing, so as to either be accommodated there or be removed.

According to a further advantageous embodiment of the invention, theclamping element comprises an elastically deformable clamping ring,which surrounds the tubular section and can be pressed by a manipulatingelement such that the ring radially clamps the tubular section, such aclamping element has a particularly simple mechanical design, isreliable, saves space and is easy to operate. It effects a non-positivefixation of the tubular section, which can also easily be releasedagain.

To this end, the clamping ring may be radially deformable by axialpressure action. The ring can be designed as an elastomeric ring forthis purpose, or as a slotted ring which is made of a plastic materialor a metal.

As an elastomeric ring, the clamping ring can be pressed flat, forexample by means of a pressure piece, wherein the ring expands radiallyinward and outward, whereby the inside diameter of the ring isdecreased. If the clamping ring is a slotted plastic or metal ring, itcan be compressed radially inward, for example under the action of awedge-shaped body on the radial outside of the ring. For this purpose,for example a ring having a wedge-shaped cross-section can be used,which is moved axially relative to the tubular element. The clampingring can also have a conical cross-section. In a preferred embodiment,it is a clamping ring which also assures a fluid-tight connectionbetween the sheath housing and the tubular element, as can beimplemented in form of the aforementioned elastomeric ring, for example.However, the sealing action can also be implemented by an additionalsealing element 73, for example when using a slotted plastic or metalring.

The clamping element may comprise a screw element, for example foraxially pressing a clamping ring. The screw element can then be used,for example, to press a pressure piece against the clamping ring in theaxial direction.

So as to facilitate the severability of portions of the tubular sectionso as to shorten the same, the tubular section can advantageously haveat least one predetermined breaking point at least at the proximal end,the predetermined breaking point being used to sever a longitudinalsection of the tubular section. In some regions, the tubular section cancomprise peripheral indents or perforations or other weakened regions ofthe material in the circumferential direction, for example, which canoptionally also be predetermined by a molecular structure.

The tubular section can likewise have one or more predetermined breakingpoints or tear lines extending the axial direction, which are known inso-called peel-away introducer sheaths. In the case of such tear lines,a sheath can be opened starting at one end by pulling two or more casingparts apart and can be pulled off. For this purpose, a tubular sectioncan also comprise handling elements at the proximal end, such as loopsor tabs.

According to the invention, the sheath device can also comprise acutting element, by means of which a part of the tubular section can besevered, or perforated, notched or scored for the purpose of easiersevering. For example, one or more blades can be inserted in the sheathhousing so that the tubular section is automatically notched when it ispushed through the sheath housing. Such notching can, for example, takeplace in the longitudinal direction of the tubular section. It is alsopossible to provide a blade which, during a rotation of the sheathhousing relative to the tubular section, creates a cut or a weakenedregion of the tubular section in the circumferential direction.

Such blades can be produced from very hard material, such as a ceramicmaterial, for example, so that even tubular sections which arereinforced, notably reinforced by a metal woven fabric, can be cut. Itis also possible to provide substantially needle-shaped blades, whichcan cut both during a movement of the tubular section in the axialdirection and during a rotation in the circumferential direction.

According to a particularly advantageous embodiment of the invention,the cutting element comprises at least one blade, which is movablyguided, notably in the sheath housing, and is notably movably guidedradially toward the catheter. Such a blade may be actuated by means of ahandle 70 which is located on the outside of the sheath housing, so thata cut for severing a portion of the tubular section can be made using asimple manual movement when pushing the tubular section out of thepatient's body and displacing it relative to the sheath housing.

In addition to a sheath device of the type described above, theinvention also relates to a catheter system comprising a catheter andsuch a sheath device, wherein according to the invention the sheathhousing advantageously may comprise a further clamping element on theproximal side of the clamping element, wherein the further clampingelement is provided so as to radially clamp the catheter or so as toradially clamp a second sheath surrounding the catheter and/or afunctional element which is connected to the catheter.

The corresponding further clamping element can, in principle, likewisecomprise a clamping ring and can, for example, have the same design asthe first clamping element so as to fix the tubular section. However,the further clamping element can also have a different design than thefirst clamping element and in general be designed in accordance with oneof the afore-described variants of a clamping element.

The invention further relates to a method for inserting a cathetercomprising a functional element disposed at the end thereof into apatient's body, wherein the catheter is inserted into the sheath housingand the tubular section and thereupon is inserted in the tubular sectioninto the patient's, the tubular section is then pulled a certaindistance out of the patient's body in the proximal direction, and theclamping elements is released and the tubular section is moved into thesheath housing.

After being moved into the sheath housing and/or pushed through thesheath housing, the tubular section can be shortened. Before or aftershortening, the tubular section can again be clamped by means of theclamping element.

The shortening is advantageously carried out by tearing open the tubularsection in the longitudinal direction, notably starting from theproximal end of the tubular section, and by then tearing it off.

BRIEF DESCRIPTION OF DRAWINGS

The invention will be shown in drawings and described hereafter based onan exemplary embodiment.

FIG. 1 is a schematic overview of a vascular system comprising aninserted first sheath;

FIG. 2 is a detailed view of a section of FIG. 1;

FIG. 3 shows an embodiment of the invention comprising a first sheathand a second sheath;

FIG. 4 shows an embodiment of a pump;

FIG. 5 shows a second sheath comprising a pump extracted therefrom;

FIGS. 6, 7 show the pulling of a pump into a second sheath;

FIGS. 8, 9 show the transfer of a pump from a second sheath into a firstsheath;

FIG. 10 is a longitudinal section through a sheath housing comprising atubular section;

FIG. 11 is a longitudinal section through a portion of a sheath housingcomprising a cutting element;

FIG. 12 is a longitudinal section through a sheath housing comprising aclamping element for the tubular section and a further clamping element;and

FIG. 13 is a longitudinal section through an alternative clamping ringcomprising a conical pressure piece.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 shows a schematic human vascular system 1. One of the femoralarteries 2 is located in the groin region and is connected to the aorticarch 3 via an aorta and then leads into the ventricle 4. An introducersheath 10 is first inserted into the femoral artery 2, for example usingthe Seldinger Technique. The femoral artery, or any blood vessel, ispunctured for this purpose, for example using a steel cannula having acutting tip. A guide wire 12 is pushed through the steel cannula, whichis inserted into the puncture site, and inserted into the left ventricle4 retrogradely via the aortic arch 3. After the puncturing cannula isremoved, the first sheath 10, which is designed as an introducer sheathand comprises a tubular section 11 and optionally a dilator, which isnot shown here, is threaded on the guide wire and inserted into thevascular system through the punctured site, wherein the sheath isinserted a short distance into the lumen of the vascular system or evento the site of use of an element to be inserted. Thereafter, a fluidpump is inserted into the vascular system through the introducer sheath10.

The tubular section 11 of the first sheath 10 is inserted into theartery such that the proximal end of the first sheath 10 is locatedoutside the femoral artery and can thus be used for inserting a pump,for example. It is thus possible to thread the pump on the guide wire 12so as to guide the pump into the left ventricle by means of the guidewire.

It is also possible to guide the tubular section 11 of the first sheath10 through the guide wire into the left ventricle and to then remove theguide wire 12 from the first sheath. A pump unit that may be present isthen guided through the first sheath volume into the vicinity of or intothe left ventricle 4.

In the present example, the method is only illustrated based on theinsertion of a pump into the left ventricle so as support a cardiacfunction. However, it is easy to see for a person skilled in the artthat the pump, or another functional element, can also be disposed andintroduced in other regions of the endogenous vascular system.

FIG. 2 shows the region of FIG. 1 in which the first sheath 10 is guidedfrom outside through the endogenous tissue into the lumen LG of thefemoral artery 2. The first sheath comprises a tubular section 11, whichis connected to a sheath housing 13 at the proximal end. The tubularsection 11 defines a lumen L1, which has an inside diameter d11. Thisinside diameter widens toward the proximal end of the tubular section 11in a trumpet-like shape in the region 14.

The sheath housing 13 contains a haemostatic valve, which is known fromthe prior art. This valve prevents fluid present in the lumen LG fromexiting to the outside through the lumen L1.

In the illustration of FIG. 3, the first sheath 10 of FIG. 2 is coupledto a second sheath 20. Only a tubular section 21, which defines a lumenL2 having an inside diameter d21, is shown of the second sheath 20. Theoutside diameter of the distal end of the second sheath 20 is such thatit can be inserted into the sheath housing 13. However, the insidediameter d21 is larger than the inside diameter d11.

A pump, which is not shown and present in the lumen L2, can now betransferred into the first sheath lumen L1 from the second sheath lumenL2 by pressing. The pump is then transported through the first sheathlumen L1 to the site in the vascular system where the pump is intendedto effect the action thereof. The pump can either be guided on a guidewire for this purpose, or it can be introduced without guide wirethrough the first sheath lumen. The first sheath can be advanceddistally to the site of use of the pump before the pump is pushed out,so as to protect the pump and the vascular walls as well as the shaftcatheter.

A possible embodiment of a pump 30 will be described in more detailbased on FIG. 4. The pump 30 comprises a distal pump unit 31 and a shaftcatheter 32, which adjoins the proximal end of the distal pump unit 31.At the proximal end, which is not shown, the shaft catheter 32 comprisesa coupling for coupling the shaft catheter 32 to a drive element. Thedrive element can be disposed outside the patient's body and causes aflexible shaft extending in the shaft catheter 32 to rotate, which inturn drives the distal pump unit 31.

The distal pump unit comprises a pump housing 33, which is produced fromintersecting nitinol struts. Portions of the nitinol housing areprovided with a coating 34, which extends distally and proximally of arotor 35 disposed in the housing 33. The rotor is connected to the shaft36 extending through the shaft catheter 32 and thus caused to rotate.The housing and the rotor can be compressed, which is to say the pump isa self-decompressible pump. The pump deploys after the distal pump unitis pushed out at the distal end of a sheath. So as to compress the pumpin preparation for the implantation, the distal pump unit is pulled intothe distal end of a sheath lumen of a second sheath. The inside diameterof the sheath lumen is at least greater than the outside diameter of theshaft catheter.

The rotor may be displaceable relative to the pump housing in the axialdirection, notably by means of an axial displacement of the drive shaft.However, the rotor may also be fixed in the axial direction relative tothe pump housing.

The pump optionally comprises an outflow hose 37, which defines a flowduct for the pumped fluid located proximally of the rotor 35. Dischargeopenings, which are not shown in detail, are located at the proximal endof the outflow hose 37.

The pump can, of course, also be switched from pumping operation tosuction operation, so that the pump no longer conducts fluid from thedistal end to the proximal end, but vice versa.

A detailed description of a further suitable pump can be found indocument EP 2 047 872 A1, for example.

The function of the system shall now be described based on FIGS. 5 to 9.

FIG. 5 shows a pump 30′, which substantially corresponds to the pump 30of FIG. 4. To simplify matters, details of the pump are not shown. Onlythe bellied housing and the “pigtail” located distal of the belliedhousing are shown, the pigtail preventing the heart pump from beingsuctioned against the cardiac wall. The shaft catheter 32′ runs proximalof the distal pump unit 31′. A second sheath 20′ is provided, whichencloses a region 38′ of the shaft catheter 32′ and comprises a lumenL2, the inside diameter d21 of which is smaller than the diameter of thedistal pump unit 31′ when it is deployed.

The pump 30′ shown in FIG. 5 is a compressible pump, which is to say thedistal pump unit 31′, which comprises the pump housing and the rotorlocated therein, among other things, is designed such that it can becompressed, which is to say that the diameter thereof can be decreased.After a quality inspector or a physician, for example, has confirmed thecorrect function of the pump 30′, such as by observing the rotationalmovement of the rotor unit located in the distal pump unit 31′ during atest run, the distal pump unit 31′ is pulled into the lumen L2 of thesecond sheath 20′ by pulling the shaft catheter 32′ in the proximaldirection. By pulling the pump into the second sheath 20′, bending ordamage of the shaft catheter or of the shaft extending therein isprevented. The pump 30′ shown in FIG. 5 and the second sheath 20′enclosing the region 38′ of the shaft catheter 32′ form a system 200which allows the function of the pump 30′ to be tested in due timebefore surgery and the pump to be compressed by pulling the distal pumpunit 31′ into the distal end of the second sheath 20′, and thus preventdamage to the shaft.

Although the system can be implemented both with actively decompressiblepumps and with self-decompressible pumps, it is particularly suitablefor self-decompressible pumps, which is to say pumps in which the distalpump unit automatically restores the original size outside the sheath.

FIG. 6 shows an intermediate step when pulling the distal pump unit 30′into the lumen of the second sheath 20′. It is apparent that the distalpump unit 30′ can be compressed and reduced to a smaller diameter, sothat the distal pump unit 30′ can be accommodated in the lumen of thesecond sheath 20′.

FIG. 6 further shows a coupling 39′ adjoining the shaft catheter 32′,the coupling allowing the shaft extending in the shaft catheter to becoupled to a drive unit. Because the coupling 39′ often times has alarger outside diameter than the inside diameter of the lumen L2, thesecond sheath 20′ is usually added from the proximal end of the shaftcatheter 32′ in the distal direction before the coupling 39′ is mounted,so that the pump is shipped as a system 200, which is to say the pumpcomprising the second sheath 20′ located proximal of the distal pumpunit 31′ and the sub-assembled coupling 39′. FIG. 6 also shows aslightly trumpet-shaped expansion of the distal end of the second sheath20′. The trumpet-shaped expansion 24′ makes it easier for the distalpump unit 31′ to be pulled into the lumen L2 of the second sheath 20′.

In FIG. 7 finally the distal pump unit 31′ is located entirely in thelumen L2 of the second sheath 20″. The second sheath 20″ comprises twosub-assembled grip units 22″, which allow better holding or removal ofthe second sheath 20″ when pulling the distal pump unit 31′ into thelumen L2, or subsequent tearing. If a “pigtail” is present, the same isadvantageously likewise pulled into the lumen L2, so that the distalpump unit 31′, together with the components of the pump located distalof the distal pump unit 31′, are present in the lumen L2.

It is apparent from FIG. 8 how the system 200 comprising the pump 30′and second sheath 20″ is combined in an operative connection with thefirst sheath 10 to form a system 100. First, the distal end of thesecond sheath 20″ is inserted into the sheath housing of the firstsheath 10. As soon as the distal tip of the second sheath 20″ is seatedagainst the mouth of the tubular section of the first sheath 10, thepump is transferred from the second sheath 20′ into the first sheath 10′by pushing the pump in the distal direction, the pushing taking place bypushing of the shaft catheter 32′. The diameter of the distal pump unit31′ is thus reduced further to the inside diameter d11 of the lumen L1.

FIG. 9 shows the subsequent step, in which the distal pump unit 31′ islocated entirely in the lumen L1 of the first sheath 10. The fact thatthe distal pump unit 31′ is located entirely in the lumen L1 of thefirst sheath 10 can be indicated, for example, by using a coloredmarking 50 which is applied to the outside of the shaft catheter 32′.

The second sheath 20″, which is designed as a “peel-away” sheath, isthen removed from the shaft catheter 32′ by tearing open the peel-awaysheath from the proximal end to the distal end and pulling it off theshaft catheter 32′. The directed tearing open from the proximal end tothe distal end can be supported by notches A, however it is primarilybased on the orientation of the molecule chains of the plastic materialthat is used from the proximal direction in the distal direction.

After the peel-away sheath has been removed, the pump 30′ is guidedfurther inside the lumen L1 of the first sheath 10 to the desiredlocation.

The first sheath can optionally be advanced to the immediate vicinity ofthe site of use before or after the pump has been inserted using thedistal sheath mouth. The first sheath has the required length to do so.

A reinforcement of the second sheath 20″ is not required, in particularwhen pulling the distal pump unit 31′ into the distal end of the secondsheath lumen L2, because the risk of the shaft kinking during a pullingmotion is significantly reduced.

When the pump is transferred from the second sheath to the first sheath,as shown based on FIGS. 7 to 9, the second sheath may comprise areinforcing structure in form of an introduced wire, or the tubularsection 21″ of the sheath 20″ is not produced from a flexible plasticmaterial, but from a non-deformable plastic material or metal.

Another option for stabilizing the pump and the second sheath is that ofholding the second sheath 20″ by way of a supporting element 40 in formof a stable outer sleeve when advancing the pump 30′ in the distaldirection, which is to say in particular when transferring the pump 30′from the second sheath into the first sheath.

Hereafter, another possible variant of a method for inserting a pumpinto a left ventricle shall be described. As a preparatory measure, thepump is first filled with a sterile physiological salt solution and isthus completely freed from air. Then, the peel-away sheath locatedproximal of the distal pump unit is advanced to a potentially presentoutflow hose. The diameter of the peel-away sheath is 10 Fr, forexample. After the peel-away sheath has been advanced to the outflowhose, the peel-away hose is surrounded by a sleeve-shaped element so asto hold the second sheath. The distal pump unit is then pulled into thepeel-away sheath, optionally by performing a slight rotational movement,by performing a pulling motion in the proximal direction on the shaftcatheter. The pump is advanced into the second sheath so far that apotentially present pigtail is likewise secured in the peel-away sheath.These steps make it possible to examine the functional capability of thepump even before surgery and to insert the pump only then into a sheath,without having to act under time pressure. For example, it is only thenthat the vascular system is punctured so as to insert the first sheath.However, so as to save time, it is thus also possible for an assistantto prepare the pump, while the user already carries out the puncturing.

After a 9 Fr introducer sheath, for example, has been introduced intothe left ventricle, a potentially present dilator is pulled out of theintroducer sheath and removed therefrom.

The pump, which is held in the peel-away sheath and which initially is,for example, enveloped by the sleeve so as to hold the second sheath, isthen pushed into the sheath housing until the tip of the peel-awaysheath strikes against a mechanical stop. The pump is then transferredfrom the peel-away sheath into the tubular section by pushing the shaftcatheter. As soon as the distal pump unit has been completelytransferred into the introducer sheath, as can be verified based on anoptical marking on the catheter shaft, for example, the peel-away sheathcan be torn open and pulled off the shaft catheter. The pump is thenadvanced inside the first sheath into the left ventricle. The firstsheath is subsequently pulled back out of the left ventricle, to thepoint where the descending aorta begins.

The positioning of the distal pump unit in the left ventricle can becontrolled by way of radioscopy, for example. For this purpose, an X-rayvisible marking is located on the pump housing or in the vicinitythereof, for example on the catheter, or the pump housing itself isvisible to X-rays. The discharge region of the pump, which is to say thedischarge openings of an outflow hose, should likewise be located in theregion of the ascending aorta. This can also be checked using an X-rayvisible marking. A potentially present pigtail catheter tip should makecontact with the tip of the left ventricle.

So as to remove the pump from the ventricle, the pump is retracted intothe introducer sheath by means of a pulling force that is applied to theshaft catheter and is removed from the arterial vascular system in thecompressed state. If the first sheath has already been shortened, thepump can also first be retracted a certain distance into the shaftcatheter so as to compress the pump. For this purpose, the shaftcatheter may comprise a pull-in funnel into which the pump can be pulledby pulling on the drive shaft. The first sheath and further remainingcomponents are then removed from the vascular system.

The invention provides a particular advantage when a long sheath is usedduring the implantation and explanation of the pump. The long sheath isnot only used, as is customary in the prior art, to insert the pump intoan endogenous lumen, but also to guide the pump through the sheath lumeninto the vicinity of the site of action. To this end it is advantageousin the medical field if the sheath has a length between 40 and 120 cm.The length is determined by the later site of action of the pump and thepatient's physique.

If the pump is pulled out of the endogenous lumen together with the longsheath, bleeding of the femoral artery is stopped by means of a pressuredressing. As an alternative, the pump can be pulled out of the sheathlumen of the long sheath. A further guide wire can then be placedthrough the lumen of the sheath, and an element for closing the puncturecan be guided via this guide wire after the sheath has been removed.This allows improved stemming of the bleeding to be achieved.

FIGS. 10 to 13 show in particular an embodiment of the first sheathaccording to the invention, comprising one or more clamping elements forfixing a tubular section 41 in a sheath housing 43.

FIG. 10 shows a longitudinal section of a sheath housing 43, whichsubstantially has the shape of a cylindrical sleeve which is closed atleast at the distal end 44 facing the patient's body by a pressure screw45. The sheath housing 43 has a continuous receiving channel 46 for atubular section 41 of the first sheath. In the illustration of FIG. 10,coming from the patient's body, the tubular section 41 is showncontinuously up to the flushing space 47 of the receiving channel 46,and then in dotted form in the proximal direction. This indicates thatthe tubular section 41 can be axially displaced relative to the sheathhousing 43 inside the receiving channel 46 or, in other words, thesheath housing 43 can be displaced on the tubular section 41.

So as to insert a functional element, for example a pump, into the firstsheath, the tubular section 41 is usually pulled out of the sheathhousing 43 in the distal direction so far, or it is positioned duringproduction of the first sheath, so that it ends approximately at thelevel of the first stop piece 48. A second sheath comprising a retractedpump, as described above, can be advanced up to this point, so as tothen move the pump from the second sheath into the first sheath.

The first clamping element comprises elements such as the first pressurescrew 45, a first clamping ring 50 made of an elastomeric material, andthe first stop piece 48.

The pressure screw is screwed to the sheath housing by means of anexternal thread in an overlapping region with the distal end 44 of thesheath housing 43. Manually rotating the pressure screw 45 thus bringsabout a movement of the pressure screw in the axial direction, whichresults in axial compression or expansion of the clamping ring 50.During an axial compression, the clamping ring 50 tends to give wayradially inward and outward so as to maintain the volume thereof andthus clamps the tubular section 41, because it experiences resistance atthe proximal side by the first stop piece 48.

The tubular section 41 is thus axially fixed relative to the sheathhousing 43. This fixation can easily be released by loosening thepressure screw 45, so that the tubular section 41 is then easy toaxially displace in the sheath housing 43. To this end, when it isrelaxed, the clamping ring can have an inside diameter that equal to orlarger than the diameter of the first sheath.

So if the tubular section 41 is first pushed as far as possible into thepatient's body to allow insertion of the pump, protected by the sheath,to the site of use, for example a ventricle, the tubular section 41 ispulled out after the pump has been removed and the sheath as a wholeprotrudes relatively little from the patient's body. The clampingelement 48, 45, 50 can then be released and the sheath housing 43 can bepushed closer to the patient's body on the tubular section 41. Thetubular section 41 then extends completely through the sheath housing 43and optionally protrudes from the same in the proximal direction. Usingmeans which will be described in more detail hereafter, the tubularsection 41 can then be severed in some regions so as to remove theexcess length.

A so-called combined haemostatic valve, which is composed of a domevalve 51 and a valve plate 52, is provided inside the sheath housing 43to provide better sealing action. The valve plate closes the sheathhousing 43 if at this point neither the tubular section 41 nor a shaftcatheter extends through the receiving channel 46, while the dome valve51 is optimized so as to provide tight sealing around a strand-shapedbody, for example the tubular section or a catheter.

A further pressure screw 54 is provided at the proximal end 53 of thesheath housing 43, the pressure screw basically functioning in the samemanner as the first pressure screw 45 and effecting the compression of asecond clamping ring 56 relative to a second mechanical stop 57 via apressure piece 55. A special feature that should be mentioned here isthat the distal end of the second clamping ring 56 has a conical shape,which favors a deformation radially inward when exerting an axialpressure by way of the pressure screw 54. The second stop 57 has aconical design in the opposite direction. However, it is also possibleat this point to use a non-conical clamping ring 56, and instead onewhich has a rectangular or round cross-section.

It is then possible to additionally dispose one or more further valvesin the flushing space between the clamping element 48, 45, 50 and theflushing inlet 58, whereby it is assured that a fluid-tight connectionexists between the tubular section 41 and the sheath housing 43, even ifthe clamping element 48, 45, 50 is released.

FIG. 10 schematically indicates a flushing element 58, which allows theflushing space 47 to be flushed with a liquid that prevents microbesfrom penetrating into the patient's body through the first sheath. Thisflushing is particularly effective if the tubular section 41 ends in theflushing space 47 or on the distal side thereof, so that the flushingliquid can reach both the outside and the inside of the tubular section41.

FIG. 11 shows, by way of example, the arrangement and operatingprinciple of a cutting element according to the invention.

If no precut predetermined breaking points, or no predetermined breakingpoints that are predefined in another manner, for example by apredetermined molecule structure or regional weakening of the wallthickness of the tubular section 21, are provided, these can beintroduced in a suitable manner when using the first sheath by way of acutting element. In the region of the flushing space 47 of the sheathhousing 43 in FIG. 11, a cutting element comprising blades 59, 60 isprovided, which cuts the tubular section in the circumferential section,for example during a rotation of the sheath housing relative to thetubular section. It is also possible to introduce cuts in the axialdirection.

For this purpose, the blades 59, 60 can also be disposed such that theycut in the longitudinal direction during a movement of the tubularsection 41 in the axial direction, as indicated by the arrow 61. It ispossible to provide blades both for cutting in the circumferentialdirection and for cutting in the longitudinal direction.

FIG. 11 also shows that the blades 59, 60 can be moved radially towardthe tubular section 41 by actuation from outside the sheath housing 43.There, a guide 72 extending in the radial direction for one or moreblade holders 70, a corresponding seal 75 and a suspension 74 can beprovided, so that microbes are prevented from penetrating via thisdisplacement element for the blades and the blades, when not actuated,radially have a distance from the tubular section 41. After use of thefirst sheath, it is then possible to manually apply pressure to theblades and the portion of the tubular section 41 that is not requiredcan be cut off. A stop 71, prevents the cutting depth from exceeding acritical dimension and causing damage to a catheter which may be presentinside the sheath.

The blades shown can also form a cutting element for a second sheath.

FIG. 12 shows an advantageous use of the second clamping element on theproximal side of the sheath housing 43 after the tubular section 41 hasbeen shortened, and a shaft catheter 61, leads out of the proximal endof the tubular section 41 and then on to a coupling element, which isnot shown, for a drivable shaft of a pump and out of the sheath housing43. The shaft catheter is sealed in the aforementioned dome seal 51, andthe clamping element, together with the elements of the second pressurescrew 54 and of the second clamping ring 56, which is axially compressedby the pressure piece 55 relative to the second stop 57, gives wayradially inward far enough for the shaft catheter 61, which has asubstantially smaller outside diameter than the tubular section 41 or asecond sheath, to be clamped and in particular to be additionallysealed. Both the tubular section 41 and the shaft catheter 61 protrudingtherefrom can thus be fixed in the sheath housing 43.

The second clamping element is likewise suitable for fixing the secondsheath with the second clamping ring 56, when inserting a second sheathinto the sheath housing 43, such that the second sheath is sufficientlyfixed relative to the sheath housing 43, and notably relative to thetubular section 41, so as to allow the shaft catheter 61 to be pushedthrough.

The first and second clamping rings 50, 56 can be produced from anelastomer, for example a rubber or a silicone elastomer, and can thus befully elastic, but be deformable without being able to compress thevolume. At this point, using an elastic foamed material in which some ofthe volume can be compressed is also conceivable.

FIG. 13 is a schematic view of another type of a clamping ring 62, whichcan be produced from a plastic material or a metal, for example, and inparticular can be slotted and thus be radially compressible. The slottedclamping ring 62 has a conical outside contour, against which theconical contour of a pressure piece 63 pushes so as to radially compressthe clamping ring as soon as an axial pressure force is exerted on thepressure piece 63 in the direction of the arrow 65, for example by apressure screw shown above. The slotted clamping ring 62 is axiallyfixed by the stop piece 64.

A first concept of the invention relates to a sheath device forinserting a catheter into a lumen, in particular of a patient's body,comprising a first sheath (10, 11, 13, 21, 21′, 21″, 41, 43) having aproximal end and a distal end, which is located in particular on thepatient body side, wherein the first sheath comprises a sheath housing(13, 43) having a receiving channel, which hereafter is referred to asthe first receiving channel, and a further receiving channel forreceiving a tubular section, which extends distally from the sheathhousing and which in particular runs coaxially relative to the firstreceiving channel and in which the tubular section can be axiallydisplaced and fixed.

The first and the further receiving channels are located in particularcoaxially relative to each other and axially behind each other, and thetubular section can also extend through both receiving channels.

A second concept of the invention relates to a sheath device accordingto the first concept, wherein the diameter of the first receivingchannel differs from the diameter of the further receiving channel.

The diameter of the first receiving channel can be smaller or largerthan the diameter of the further receiving channel. However, it is alsoconceivable for the diameter of the first receiving channel tosubstantially correspond to the diameter of the further receivingchannel.

According to a third concept of the invention, a clamping element (54,54′, 55, 56, 56′, 57, 57′) for fixing a strand-shaped body in the firstreceiving channel and/or for fixing a tubular section (11, 21, 21′, 21″,41) in the further receiving channel by way of clamping can be providedin the first receiving channel (46) and/or in the further receivingchannel according to the first concept or the second concept of theinvention.

At least one of the clamping elements (54, 54′, 55, 56, 56′, 57, 57′)can, for example, be designed such that it selectively allows clampingof a strand-shaped body having a first diameter or of a strand-shapedbody having a second diameter, wherein the first diameter is differentfrom the second diameter.

For this purpose, for example, a clamping mechanism comprising aclamping screw can be provided, which has several preferred clampingpositions. These can, for example, be implemented by various positionsof the clamping screw.

According to a fourth concept of the invention, which relates to asheath device according to the first, second or third concept,additionally a radial expansion of the first or further receivingchannel containing a flushing element can be provided in the sheathhousing (13, 43) in the region of the first receiving channel and/or thefurther receiving channel.

The flushing element can, for example, comprise one or more radial fluidconnections for supplying and removing a fluid.

In the region of the radial expansion, for example at one of the axialends thereof, additionally a valve can be provided for closing off theradial expansion in a fluid-tight manner.

The valve may comprise a valve plate and/or a dome valve.

A fifth concept of the invention relates to a sheath device according tothe first or any one of the subsequent concepts (2 to 4) of theinvention, wherein a cutting device comprising at least one blade isprovided, which has at least one possible position, in which it radiallyprotrudes into the first receiving channel or into the further receivingchannel or into the expanded region, and more particularly into theflushing space.

For example, at least one blade that cuts in the circumferentialdirection of a receiving channel or a blade that cuts in the axialdirection may be provided for this purpose. The respective blade(s) caneach be displaceable in the radial direction with respect to thereceiving channel or the expanded region between at least one cuttingposition and a non-cutting position, in particular a position that doesnot protrude into a receiving channel. The displacement can take placeagainst the counterforce of a spring 76, which cooperates with the knifeor a knife holder.

In addition, a fluid-tight guide channel can be provided for each of theknives.

A sixth concept of the invention relates to a sheath device according tothe first or any one of the subsequent concepts (2 to 5) of theinvention, comprising a tubular section that is located in the furtherreceiving channel.

A seventh concept of the invention relates to a catheter devicecomprising a sheath device according to any one of the precedingconcepts and comprising a catheter, which extends through the receivingchannel on the inside and together with a second sleeve-shaped sheath,wherein the second sheath is fixed in the first receiving channel, inparticular in a clamping element (54, 54′, 55, 56, 56′, 57, 57′) of thefirst receiving channel.

An eighth concept of the invention relates to a method for inserting acatheter (32, 66) into a patient's body by means of a sheath deviceaccording to any one of the preceding concepts of the invention and bymeans of a second sheath (20, 20′, 20″, 20′″), wherein first the secondsheath, together with the catheter, is inserted into the first sheath(10, 11, 13, 21, 21′, 21″, 41′, 43), and more particularly up to the endof the tubular section and abutting the same, the second sheath is thenfixed by means of a clamping element (54, 54′, 55, 56, 56′, 57, 57′),and thereafter the catheter is transferred from the second sheath intothe first sheath.

A ninth concept of the invention relates to a method according to theninth concept, wherein the second sheath (20, 20′, 20″, 20′″) isremoved, in particular by tearing it open or off, after the catheter hasbeen inserted into the first sheath.

A tenth concept of the invention relates to a method according to theeighth or ninth concept, wherein the catheter is fixed in a clampingelement (54, 54′, 55, 56, 56′, 57, 57′) after the second sheath (20,20′, 20″, 20′″) has been removed.

An eleventh concept of the invention relates to a method for inserting acatheter into a patient's body by means of a sheath device according toany one of the preceding concepts of the invention, wherein a tubularsection (11, 21, 21′, 21″, 41) is introduced into the sheath housing(13, 43) and likewise is introduced into a lumen of a patient's body,wherein then a functional element is introduced into the lumen of thepatient's body through the sheath device, wherein then the tubularsection is pulled at least a certain distance out of the lumen of thepatient's body, wherein the sheath housing is displaced in the distaldirection relative to the tubular section, and wherein then the tubularsection is fixed on the sheath housing by means of a clamping elementand/or is cut off inside the sheath housing.

The invention claimed is:
 1. An introducer sheath device comprising: asheath housing having a guide channel extending in a radial direction; afirst sheath located within the sheath housing and configured to move ina longitudinal direction relative to the sheath housing, the sheathconfigured to allow passage of a catheter therein; and a cutting devicecomprising a first blade moveably positioned between the sheath and thesheath housing, wherein the first blade is configured to cut the sheathas the first blade moves in the longitudinal direction relative to thesheath housing and wherein the guide channel is a fluid tight channelthrough the sheath housing.
 2. The sheath device of claim 1, wherein thecutting device further comprises a second blade positioned opposite thefirst blade within the sheath housing.
 3. The sheath device of claim 2,wherein the first blade and the second blade cut the sheath in thelongitudinal direction during a movement of the first sheath in an axialdirection.
 4. The sheath device of claim 3, wherein the first blade cutsin the longitudinal direction, the second blade cuts in acircumferential direction, and wherein the cutting device furthercomprises a third blade, wherein the third blade cuts in thecircumferential direction.
 5. The sheath device of claim 1, wherein theguide channel extending in a radial direction comprises at least one of:at least one blade holder; a sealing element providing a fluid-tightconnection between the sheath housing and the first sheath; or asuspension element.
 6. The sheath device of claim 5, wherein the guideis configured to displace the first blade in the radial direction. 7.The sheath device of claim 6, wherein the first blade is displaceablebetween at least one cutting position and a non-cutting position.
 8. Thesheath device of claim 7, wherein in the non-cutting position the firstblade does not protrude into a receiving channel of the first sheath. 9.The sheath device of claim 7, wherein the guide further comprises aspring which provides a counterforce for displacement of the firstblade.
 10. The sheath device of claim 1, wherein the fluid-tight guidechannel encloses the first blade.
 11. The sheath device of claim 1,further comprising a second sheath fixed within the first sheath, thesecond sheath configured to allow passage of the catheter therethrough.12. The sheath device of claim 11, wherein the second sheath is fixed bya clamping element of the sheath housing.
 13. The sheath device of claim11, wherein the first sheath is configured to allow passage of thecatheter from the second sheath into the first sheath.
 14. The sheathdevice of claim 13, wherein the first blade is configured to cut thesecond sheath after passage of the catheter therethrough.
 15. The sheathdevice of claim 1, wherein a blood pump is connected to a distal end ofthe catheter.
 16. A method for using a sheath cutter device, the methodcomprising: inserting a first sheath into a sheath housing, the sheathhousing including a first blade positioned between the sheath and thesheath housing; actuating a movement of the first blade in a radialdirection within the sheath housing from a non-cutting position to acutting position, wherein the movement of first blade is configured tocut the first sheath; and cutting the first sheath with the first blade.17. The method of claim 16, wherein the first blade is actuated by aguide having at least one of a blade holder, a sealing element, or asuspension element.
 18. The method of claim 16, further comprising:clamping a second sheath within the first sheath, wherein the secondsheath is clamped by a clamping element of the sheath housing.
 19. Themethod of claim 18, wherein the second sheath encloses a catheter, andwherein the first sheath and the second sheath are configured to allowpassage of the catheter therethrough.
 20. The method of claim 19,further comprising: transferring the catheter from the second sheath tothe first sheath.
 21. The method of claim 20, further comprising:actuating the movement of the first blade within the sheath housing,wherein the movement of the first blade is configured to cut the secondsheath; and cutting the second sheath with the first blade.
 22. Thesheath device of claim 2, wherein the first blade cuts in thelongitudinal direction, and the second blade cuts in a circumferentialdirection.